Food, drugs, devices › Micro-X Ltd.
Device recall: Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71
Micro-X Ltd. (Tonsley, N/A) initiated this device recall on 27 Mar 2026; FDA lists 1 product record under event 98644, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 87% of the 572 device enforcement events initiated in 2026 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Micro-X Ltd. has 8 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Micro-X Ltd., Tonsley, N/A, Australia.
Reason for recall
"X-Ray generator may malfunction resulting in the X-Ray being inoperable."
Distribution
"US Nationwide distribution in the states and territories of WA, NJ, CA, Puerto Rico."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1918-2026 | Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71 | 32 units | Class II | Ongoing | 29 Apr 2026 |
Context
Other enforcement events for Micro-X Ltd.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 4 Apr 2025 | Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35 Product Description: Rover | Device | Class II | 2 |
| 28 Mar 2025 | Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 Product Description: Rover Mobile X-r | Device | Class II | 2 |
| 23 Oct 2024 | MICRO-X Rover Mobile X-ray System, # MXU-RV19 | Device | Class II | 1 |
| 22 Oct 2024 | MICRO-X Rover Mobile X-ray System, # MXU-RV35 | Device | Class II | 1 |
| 28 Nov 2023 | MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71 | Device | Class II | 1 |
| 31 May 2023 | MICRO-X Rover Mobile X-ray System, # MXU-RV35 | Device | Class II | 1 |
| 31 Aug 2022 | MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19 | Device | Class II | 1 |
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "X-Ray generator may malfunction resulting in the X-Ray being inoperable."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution in the states and territories of WA, NJ, CA, Puerto Rico."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.